Indications and Coverage of Metabolic and Bariatric Surgery: A Worldwide IFSO Survey Comparing Different National Guidelines.

INTRODUCTION: Knowing how metabolic and bariatric surgery (MBS) is indicated in different countries is essential information for the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). AIM: To analyze the indications for MBS recommended by each of the national societies that comprise the IFSO and how MBS is financed in their countries. METHODS: All IFSO societies were asked to fill out a survey asking whether they have, and which are their national guidelines, and if MBS is covered by their public health service. RESULTS: Sixty-three out of the 72 IFSO national societies answered the form (87.5%). Among them, 74.6% have some kind of guidelines regarding indications for MBS. Twenty-two percent are still based on the US National Institute of Health (NIH) 1991 recommendations, 43.5% possess guidelines midway the 1991s and ASMBS/IFSO 2022 ones, and 34% have already adopted the latest ASMBS/IFSO 2022 guidelines. MBS was financially covered in 65% of the countries. CONCLUSIONS: Most of the IFSO member societies have MBS guidelines. While more than a third of them have already shifted to the most updated ASMBS/IFSO 2022 ones, another significant number of countries are still following the NIH 1991 guidelines or even do not have any at all. Besides, there is a significant number of countries in which surgical treatment is not yet financially covered. More effort is needed to standardize indications worldwide and to influence insurers and health policymakers to increase the coverage of MBS.

Neural predictors of 12-month weight loss outcomes following bariatric surgery.

BACKGROUND/OBJECTIVES: Despite the effectiveness of bariatric surgery, there is still substantial variability in long-term weight outcomes and few factors with predictive power to explain this variability. Neuroimaging may provide a novel biomarker with utility beyond other commonly used variables in bariatric surgery trials to improve prediction of long-term weight-loss outcomes. The purpose of this study was to evaluate the effects of sleeve gastrectomy (SG) on reward and cognitive control circuitry postsurgery and determine the extent to which baseline brain activity predicts weight loss at 12-month postsurgery. SUBJECTS/METHODS: Using a longitudinal design, behavioral, hormone and neuroimaging data (during a desire for palatable food regulation paradigm) were collected from 18 patients undergoing SG at baseline (<1 month prior) and 12-month post-SG. RESULTS: SG patients lost an average of 29.0% of their weight (percentage of total weight loss (%TWL)) at 12-month post-SG, with significant variability (range: 16.0-43.5%). Maladaptive eating behaviors (uncontrolled, emotional and externally cued eating) improved (P<0.01), in parallel with reductions in fasting hormones (acyl ghrelin, leptin, glucose, insulin; P<0.05). Brain activity in the nucleus accumbens (NAcc), caudate, pallidum and amygdala during desire for palatable food enhancement vs regulation decreased from baseline to 12 months (P (family-wise error (FWE))<0.05). Dorsolateral and dorsomedial prefrontal cortex activity during desire for palatable food regulation (vs enhancement) increased from baseline to 12 months (P(FWE)<0.05). Baseline activity in the NAcc and hypothalamus during desire for palatable food enhancement was significantly predictive of %TWL at 12 months (P (FWE)<0.05), superior to behavioral and hormone predictors, which did not significantly predict %TWL (P>0.10). Using stepwise linear regression, left NAcc activity accounted for 54% of the explained variance in %TWL at 12 months. CONCLUSIONS: Consistent with previous obesity studies, reward-related neural circuit activity may serve as an objective, relatively robust predictor of postsurgery weight loss. Replication in larger studies is necessary to determine true effect sizes for outcome prediction.

Association of metabolic syndrome and surgical factors with pulmonary adverse events, and longitudinal mortality in bariatric surgery.

BACKGROUND: Postoperative pulmonary complications (PPC) in bariatric surgery have not been well studied. Additionally, many bariatric patients suffer from the metabolic syndrome (MetS), contributing to surgical risk. We examined the incidence of PPC and MetS in a large national bariatric database. Furthermore, we analysed the relationships between morbidity, mortality, PPC, MetS, and several other comorbidities and also surgical factors. METHODS: The Bariatric Outcomes Longitudinal Database (BOLD™) is a registry that includes up to 365 day outcomes. We analysed data between January 2008 and October 2010. The PPC tracked included pneumonia, atelectasis, pleural effusion, pneumothorax, adult respiratory distress syndrome, and respiratory failure. A composite pulmonary adverse event (CPAE) included the occurrence of any of these. MetS was defined as the combination of hypertension, dyslipidaemia, and diabetes mellitus. The association of MetS and additional comorbibities, procedural data, and patient characteristics with CPAEs was examined with appropriate statistical tests. RESULTS: A total of 158 405 patients had a low incidence of PPC (0.91%) and a low mortality (0.6%) after bariatric surgery. MetS was prevalent in 12.7%, and was a significant risk factor for CPAE and mortality. Age, BMI, ASA physical status classification, surgical duration, procedure type, MetS (P<0.001), and additional comorbidities were significantly associated with CPAEs. CONCLUSIONS: The incidence of PPC was low after bariatric surgery. Increasing age, BMI, ASA status, MetS, obstructive sleep apnoea, asthma, congestive heart failure, surgical duration, and procedure type were independently significantly associated with PPC. Pulmonary complications and MetS were significantly associated with increased postoperative mortality.

Vagal blocking improves glycemic control and elevated blood pressure in obese subjects with type 2 diabetes mellitus.

BACKGROUND: An active device that downregulates abdominal vagal signalling has resulted in significant weight loss in feasibility studies. OBJECTIVE: To prospectively evaluate the effect of intermittent vagal blocking (VBLOC) on weight loss, glycemic control, and blood pressure (BP) in obese subjects with DM2. METHODS: Twenty-eight subjects were implanted with a VBLOC device (Maestro Rechargeable System) at 5 centers in an open-label study. Effects on weight loss, HbA1c, fasting blood glucose, and BP were evaluated at 1 week to 12 months. RESULTS: 26 subjects (17 females/9 males, 51 ± 2 years, BMI 37 ± 1 kg/m(2), mean ± SEM) completed 12 months followup. One serious adverse event (pain at implant site) was easily resolved. At 1 week and 12 months, mean excess weight loss percentages (% EWL) were 9 ± 1% and 25 ± 4% (P < 0.0001), and HbA1c declined by 0.3 ± 0.1% and 1.0 ± 0.2% (P = 0.02, baseline 7.8 ± 0.2%). In DM2 subjects with elevated BP (n = 15), mean arterial pressure reduced by 7 ± 3 mmHg and 8 ± 3 mmHg (P = 0.04, baseline 100 ± 2 mmHg) at 1 week and 12 months. All subjects MAP decreased by 3 ± 2 mmHg (baseline 95 ± 2 mmHg) at 12 months. CONCLUSIONS: VBLOC was safe in obese DM2 subjects and associated with meaningful weight loss, early and sustained improvements in HbA1c, and reductions in BP in hypertensive DM2 subjects. This trial is registered with ClinicalTrials.gov NCT00555958.

Neuro-modulation and bariatric surgery for type 2 diabetes mellitus.

Obesity has reached epidemic proportions and is continuing to grow into one of the leading healthcare issues worldwide. With this development, bariatric surgery has emerged as an acceptable treatment for morbid obesity, generally achieving meaningful and sustained weight loss. In a surprising turn of events, bariatric surgery was also found to be the most effective therapy for type 2 diabetes mellitus (T2DM). This observation has sparked a great deal of research that has improved our understanding of T2DM pathophysiology; it has facilitated the development of medical treatment and is expanding the indications for bariatric surgery. It was traditionally accepted that bariatric surgery causes weight loss by restriction of gastric volume, intestinal malabsorption, or a combination of the two. Laparoscopic adjustable gastric banding (LAGB) is considered a purely restrictive procedure that involves the placement of an adjustable band around the cardia of the stomach, creating a 15 ml pouch. Laparoscopic sleeve gastrectomy (LSG) is the resection of the fundus all along the greater curvature of the stomach. LSG was once considered a restrictive procedure, but this presumption has recently come under scrutiny. Bilio-pancreatic diversion (BPD) is an example of a procedure that was considered predominantly malabsorptive. In this operation, the ingested nutrients are diverted from the stomach to the ileum, bypassing a large segment of proximal bowel. Roux-en-Y gastric bypass (RYGB) traditionally combines both mechanisms, partitioning a small pouch from the proximal stomach and diverting the ingested nutrients to the jejunum with a roux-en-Y gastro-jejunostomy. However, recent investigation suggests additional mechanisms of action including hormonal. Today, RYGB is the procedure of choice for morbidly obese patients. The effect of bariatric surgery on T2DM was initially described in 1995 by Pories et al., who reported that there was an overall T2DM resolution after RYGB of 82.9% (1). A resolution rate of approximately 80% has been demonstrated repeatedly (2,3). The initial assumption was that the mechanism causing this effect was through weight loss. It is becoming evident that the anti-diabetic effect is not entirely weight loss as there is a consistent observation that the improvement of glucose and insulin levels occurs within days after RYGB, clearly too soon to be due to the weight loss (1,4). The ensuing body of literature has generated two leading theories attempting to explain this weight-independent anti-diabetic effect after RYGB. The 'hindgut' proposes that rapid delivery of partially digested nutrients to the distal bowel up-regulates the secretion of incretins such as glucagon-like peptide-1 (GLP-1). The result of the increased incretin secretion is an enhanced glucose-dependent insulin secretion, as well as a number of other changes causing improved glucose tolerance (4). In the second theory, 'the foregut hypothesis', the exclusion of the duodenum results in the inhibition of a 'putative' signal that is responsible for insulin resistance (IR) and/or abnormal glycaemic control. In a non-obese diabetic rat model, surgical diversion of the proximal bowel caused rapid improvement of diabetes without reduction of food intake or change in weight (5). Many aspects regarding surgical treatment of T2DM are still questionable and unexplained. Emerging data are starting to clarify the mechanisms participating in the anti-diabetic effect, and also challenging long-held theories.

Acute technical feasibility of an endoscopic duodenal-jejunal bypass sleeve in a porcine model: a potentially novel treatment for obesity and type 2 diabetes.

BACKGROUND: The concept of endoluminal therapy for various disease states has gained significant attention. This report describes the authors' initial animal experience with a novel endoscopic duodenal-jejunal bypass sleeve (DJBS) in a porcine model. The DJBS consists of an implant delivered endoscopically, anchored in the proximal duodenum, and extended into the jejunum. This device aims to mimic the intestinal bypass effects of Roux-en-y gastric bypass without the need for stapling or anastomosis and may offer novel therapeutic benefit for patients with obesity, type 2 diabetes, or both. METHODS: Five DJBS devices were delivered in five domestic, female Yorkshire pigs. The devices were delivered and retrieved the same day and left in situ for less than 1 h. The animals were kept alive for 4 days after explantation for evaluation of their general health after the procedure. After they were killed, gastric, duodenal, and jejunal tissues were examined and harvested for histologic assessment of any acute device or procedure-related effects. RESULTS: Delivery of the implant took an average of 18 min (range, 10-38 min) and required an average fluoroscopy time of 8.1 min (range, 3.8-16.6 min). Retrievals were performed in an average of 7.4 min (range, 5-9 min) using fluoroscopy for an average of 2.3 min (range, 1.3-4.5 min). Followed for 4 days after explantation, the animals were normal and healthy. There were no pathologic findings in the explanted tissue. CONCLUSIONS: The DJBS can be safely deployed and retrieved endoscopically. Future long-term survival studies are warranted to help define the role of promising technology.

Chronic in-vivo experience with an endoscopically delivered and retrieved duodenal-jejunal bypass sleeve in a porcine model.

BACKGROUND: The role of duodenal bypass as an underlying mechanism of action in gastric bypass surgery has received considerable attention. We report the initial feasibility study of a totally endoscopically delivered and retrieved duodenal-jejunal bypass sleeve in a chronic porcine model. METHODS: The implant consists of a 60-cm fluoropolymer sleeve that is endoscopically deployed via a coaxial catheter system into the jejunum and fixed in the proximal duodenum with a Nitinol anchor. The system creates a proximal biliopancreatic diversion. Six female Yorkshire pigs were endoscopically implanted; all survived. Four animals (group 1) were slated to survive 90 days, two animals (group 2) for 120 days, and three animals (group 3) underwent sham endoscopy and were survived 120 days. Animals were fed standard dry pig chow 0.5 kg three times daily. Data points included daily general health, weekly weight, serum blood tests (complete blood count, amylase, lipase, liver function tests), and monthly evaluation of anchor/sleeve position/patency by fluoroscopy and endoscopy. Following the in-vivo period, the devices were endoscopically removed and the animals were sacrificed. Duodenal and jejunal tissue samples were assessed histologically. RESULTS: All six test animals were implanted and explanted without significant adverse events. In group 1, the first animal had no device-related issues. The second animal had a pivoted anchor requiring repositioning at day 63. That animal had no further difficulties. The third animal had an incidental partial rotation of the anchor noted at the 90 day explantation. The fourth animal was incidentally implanted with a crossover of the anchor struts, which was endoscopically corrected on day 14. However, on day 20 the animal had persistent vomiting, and the device was explanted. Both group 2 animals survived 120 days. One animal had a partially rotated anchor but was asymptomatic. The average weight gain between test and sham groups was 0.23 kg/day and 0.42 kg/day, respectively (p = 0.01). CONCLUSIONS: A totally endoscopic and reversible bypass of the duodenum and proximal jejunum has been achieved for 90-120 days. Initial experience suggests patency of the sleeve and acceptable tissue response. Reduced weight gain in the test animals suggests device efficacy. Further investigation is warranted.

Binge eating disorder in extreme obesity.

OBJECTIVE: To determine whether extremely obese binge eating disorder (BED) subjects (BED defined by the Eating Disorder Examination) differ from their extremely obese non-BED counterparts in terms of their eating disturbances, psychiatric morbidity and health status. DESIGN: Prospective clinical comparison of BED and non-BED subjects undergoing gastric bypass surgery (GBP). SUBJECTS: Thirty seven extremely obese (defined as BMI > or = 40 kg/m(2)) subjects (31 women, six men), aged 22-58 y. MEASUREMENTS: Eating Disorder Examination 12th Edition (EDE), Three Factor Eating Questionnaire (TFEQ), Structured Clinical Interview for the Diagnostic and Statistical Manual-IV (SCID-IV), Short-Form Health Status Survey (SF-36), and 24 h Feeding Paradigm. RESULTS: Twenty-five percent of subjects were classified as BED (11% met full and 14% partial BED criteria) and 75% of subjects were classified as non-BED. BED (full and partial) subjects had higher eating disturbance in terms of eating concern and shape concern (as found by the EDE), higher disinhibition (as found by the TFEQ), and they consumed more liquid meal during the 24 h feeding paradigm. No difference was found in psychiatric morbidity between BED and non-BED in terms of DSM-IV Axis I diagnosis. The health status scores of both BED and non-BED subjects were significantly lower than US norms on all subscales of the SF-36, particularly the BED group. CONCLUSION: Our findings support the validity of the category of BED within a population of extremely obese individuals before undergoing GBP. BED subjects differed from their non-BED counterparts in that they had a greater disturbance in eating attitudes and behavior, a poorer physical and mental health status, and a suggestion of impaired hunger/satiety control. However, in this population of extremely obese subjects, the stability of BED warrants further study.

The thermodilution technique for measuring resting energy expenditure does not agree with indirect calorimetry for the critically ill patient.

BACKGROUND: The complications associated with overfeeding critically ill patients are well documented. Indirect calorimetry is touted as the gold standard for measuring resting energy expenditure (REE). Unfortunately, the device is expensive, and many centers do not have this technology. The thermodilution technique for measuring cardiac output and calculating REE using the Fick equation has been reported to be an acceptable alternative. This study compared these techniques in a critically ill population. METHODS: Forty consecutive patients with indwelling Swan-Ganz catheters in the surgical intensive care unit were prospectively studied while under the consultative care of the nutrition support service. REE was determined in all patients by both techniques within a 2-hour period. An error of 5% (approximately+/-100 kcal/d) between the two methods was deemed acceptable for clinical use. RESULTS: Mean values for REE were 1928+/-558 vs 1898+/-518 kcal/d for the indirect calorimetry and thermodilution methods, respectively, and were not significantly different. However, there was great variation between the two techniques for the majority of patients such that REE determinations did not agree (t = 6.8; p < .0005). In 70% of the patients, REE determinations differed by > or =20% and in 10% of the patients by 50%. Additionally, the greater the difference between the two methods, the more the thermodilution method tended to overestimate REE. CONCLUSIONS: When compared with indirect calorimetry in a critically ill population, the thermodilution method demonstrated an intersubject variability that is unacceptable for clinical use.

Nonsurgical factors that influence the outcome of bariatric surgery: a review.

OBJECTIVE: Severe obesity (ie, at least 100% overweight or body mass index > or =40 kg/m2) is associated with significant morbidity and increased mortality. It is apparently becoming more common in this country. Conventional weight-loss treatments are usually ineffective for severe obesity and bariatric surgery is recommended as a treatment option. However, longitudinal data on the long-term outcome of bariatric surgery are sparse. Available data indicate that the outcome of bariatric surgery, although usually favorable in the short term, is variable and weight regain sometimes occurs at 2 years after surgery. The objective of this study is to present a review of the outcome of bariatric surgery in three areas: weight loss and improvement in health status, changes in eating behavior, and psychosocial adjustment. The study will also review how eating behavior, energy metabolism, and psychosocial functioning may affect the outcome of bariatric surgery. Suggestions for additional research in these areas are made. METHOD: Literature review. RESULTS: On average, most patients lose 60% of excess weight after gastric bypass and 40% after vertical banded gastroplasty. In about 30% of patients, weight regain occurs at 18 months to 2 years after surgery. Binge eating behavior, which is common among the morbidly obese, may recur after surgery and is associated with weight regain. Energy metabolism may affect the outcome of bariatric surgery, but it has not been systematically studied in this population. Presurgery psychosocial functioning does not seem to affect the outcome of surgery, and psychosocial outcome is generally encouraging over the short term, but there are reports of poor adjustment after weight loss, including alcohol abuse and suicide. CONCLUSIONS: Factors leading to poor outcome of bariatric surgery, such as binge eating and lowered energy metabolism, should be studied to improve patient selection and outcome. Long-term outcome data on psychosocial functioning are lacking. Longitudinal studies to examine the long-term outcome of bariatric surgery and the prognostic indicators are needed.

Nutritional support of the mechanically ventilated patient.

As with all critically ill patients, those requiring mechanical ventilation are susceptible to the wasting of illness and cannot survive without prompt nutritional support. It may be fair to say that the proper provision of nutrients, and in particular the avoidance of overfeeding, are even more crucial for this subset of critically ill patients. To maximize the overall benefits of feeding, it is crucial to provide the nutritional support early and enterally whenever possible. Therefore, the best strategy for early removal of the mechanical ventilatory support must include the timely and careful administration of nutrients, micronutrients, minerals, vitamins, and fluid, in conjunction with standard intensive care therapeutics and the appropriate respiratory muscle-strengthening program.

Group I: choosing the appropriate method of placement of an enteral feeding tube in the high-risk population.

The traditional nasogastric/nasoenteric feeding tube is the preferred access device for short-term feeding (< 30 days), with delivery into the stomach suggested unless aspiration or motility abnormalities are present. Preference for a long-term access device is operator- and facility-dependent. Endoscopic or fluoroscopic placement is preferred as first choices over laparoscopic placement because of considerations of cost, need for general anesthesia, and need for operating room time. Gastrostomy is preferred over intestinal placement for long-term access unless problems with aspiration or motility abnormalities exist.

Enteral nutrition and the critically ill.

Critically ill patients invariably require nutritional intervention. Traditionally, enteral nutrition has not been widely employed in this patient population. This is due in part to the success of present-day parenteral nutrition, and to difficulties encountered with enteral feeding. Recent evidence has demonstrated that enteral is preferable to parenteral nutrition in terms of cost, complications, gut mucosal maintenance, and metabolic and immune function. Enterally administered nutritional support can and should be utilised as the preferred route of nourishment for the critically ill. The appropriate choice of access and formula, as well as a rational strategy for implementation, should improve the likelihood of success. This article describes the unique features of critical illness as they pertain to nutritional support, the benefits of enteral nutrition, and the obstacles to success, and offers suggestions which may improve the ability to provide nutrients adequately via the intestinal tract.

A technique for the exchange of tunneled polymeric silicone catheters and implantable infusion ports.

Tunneled polymeric silicone catheters and implantable infusion ports are used with increasing frequency. Complications may occur with catheter placement or ongoing use. A new technique is described that minimizes the risks associated with catheter reinsertion in patients with tunneled polymeric silicone catheters that are either malfunctioning or mispositioned. This procedure allows for the exchange of these catheters without incurring the risk of a new venipuncture.

Approaches to nutritional support for battle casualties and trauma: current military practice and lessons learned from the civilian sector.

In conflict, military medicine differs greatly from its civilian counterpart. Treatment strategies are designed to manage a potentially large number of severely wounded and function in an often hostile and poorly equipped environment. The most severely injured are stabilized and prepared for transport away from the war zone to a larger, better-equipped facility. At present no formal military policy exists concerning nutrition support. Traditionally, it has not been employed until the wounded arrived at a major medical center. Factors including the limited capacity to transport formula, lack of sophistication of battle zone facilities, and the rapid movement of wounded have been major drawbacks to providing early nutrition. The care of the urban trauma patient is relevant for the battle wounded of the military. There is ample evidence in the literature to support the use of nutrition support soon after injury. This article briefly describes the limitations of the military medical system in reference to nutrition support and the role of nutrition support for the civilian trauma patient. The lessons learned from the civilian experience may help formulate a nutrition strategy for the battle wounded that may become included into the standardized care policy.